Overview Day 1Day 2Download PDFPress Pass Request Brochure
Overview Day 1Day 2Download PDFPress Pass Request Brochure
Tuesday, October 27, 2009
7:45 Morning Coffee
8:00 Chairperson’s Day Two Welcome
SITE TRAINING CONSIDERATIONS
8:00 Building an Effective Research Education Program
Melissa Kadar, Research Manager, Center for Clinical Research, Cleveland Clinic
The Human Subject Research Education Program at Cleveland Clinic provides training in the core principles of human subject research. The program was established to create an accepted level of basic education and experience for the Human Subject Research Professional recognized across the CCHS research community. This presentation will provide project management concepts used in development of the program, incorporating tests and competencies to assure accountability of research professionals. The presentation will provide practical project management (step by step) concepts to building effective education workshops. This will be useful for an institution considering the development of their own program. The audience will gain best practices and lessons learned in developing a new education program, incorporating both internal and external sources for curriculum development.
8:45 Strategies for Proactively Promoting Site-Focused Training
Lori Vivian, RN, BSN, CCRP, Clinical Research Manager II, Vascular Surgery Academic Coordinating Center, Cleveland Clinic
Site training can be a very difficult undertaking, due to their varied availability and learning styles. In this session, we will explore an effective strategy for multi-center site training. The Cleveland Clinic approach is multifaceted in that site training is provided at several times in several different formats to accommodate each study coordinator and PI’s busy schedule and their most effective learning style. This approach evolved over the course of one of our seven-year studies. We found that many more sites were trained in a shorter amount of time when we did the training using this multifaceted approach. Depending on the depth of training (initial protocol training or an amendment training), we use lecture, interactive methods, and everything in between, including recorded lecture for a more independent training.
9:30 Case Study: Strategies for Proactively Promoting Site-Focused Training
Denise Finley, Director - Clinical Learning and Development, Boston Scientific
The application of best practices in accordance with Good Clinical Practice to manage investigational sites is critical to the success of a clinical trial. Sponsor personnel need to be adequately trained to respond to real life situations in a timely manner. In order to better prepare sponsor personnel to effectively manage investigational sites, an eLearning program entitled “Situational Good Clinical Practice” was developed at Boston Scientific. During this presentation, we will present the details of Boston Scientific’s scenario-based eLearning course, which requires the learner to correctly choose the best practice for multiple challenges by reviewing a situation, viewing conversations between site personnel, and reviewing essential documents and medical records. The presentation will cover the overall approach, the learning mechanics involved, as well as how the learner solves the challenge and progresses to the next step.
10:15 Coffee Break and Exhibit Viewing
10:30 Linking Master to Novice: Mentoring Clinical Research Professionals
Megan Domenico, MBA, RN, Clinical Manager, Clinical Research Unit, Children’s Memorial Hospital, Chicago
In many different settings, mentoring has shown to develop quality employees, facilitate the sharing of knowledge and ideas, and empower staff to excel in their careers. Most academic institutions operate clinical research in “silos” divided by medical specialty, resulting in small research teams limiting knowledge and experience to only that group. In some cases, these groups contain one or only a few research coordinators and as staff turns over much, if not all, of the knowledge and experience is lost. The difference between a quality, experienced coordinator and a poorly trained or novice coordinator could translate to regulatory compliance issues, breach of human subject protection, inadequate budget management, and recruitment losses. Establishing a mentoring program that links expert coordinators with novice coordinators is critical to quality clinical research, as well as a mutually beneficial arrangement between the two coordinators. Audience members will gain knowledge on the structure and function of a mentoring program. In addition, they will understand the financial detriment of time lost as new coordinators “learn the ropes” on their own, and the potential cost of mistakes made along the way.
11:15 Maximizing Training Content and Resources across Clinical Research Job Functions
Bertha Robbins, RNC, MS, CCRP, Clinical Research Manager for the Clinical Trials Unit, Connecticut Children’s Medical Center
In the current economic climate, the ability to conduct research at institutions has been under closer scrutiny. A successful research program must encompass a system of collaboration for education, regulatory, monitoring, operations functions, human subject protections, patient safety, quality improvement, fiscal management, and research compliance. A coordinated program that successfully oversees these activities provides the best utilization of scarce resources and maximizes clinical research personnel as clinical research waxes and wanes. Centralization of personnel and services assures that all clinical research for each study is conducted under the same high standards. This allows for all clinical research personnel to have available mentors to collaborate with to provide safe and ethical conduct of research at the institution. One important aspect of such a program is to have a formalized orientation program for new personnel that encompass all the functions that are specific to clinical research. Once such a program is put into place, coverage for research studies can be shifted quickly as new studies are opened and others are completed. This also allows for coverage for vacations and off hours without sacrificing safety and quality. This collaboration encourages clinical research personnel to both support and learn from each other, enhancing job satisfaction.
12:00 Luncheon (on your own)
LEARNING METHODS, TRANING TECHNIQUES,
AND BEST PRACTICES
1:30 Applying an Activating Learning Approach to ICH GCP Training
Gerlinde Jayme, Head Learning Management, Process & Capability Improvement/Clinical Information and Learning Management, EMD Serono
Carola Beier, Global Training Manager, Process & Capability Improvement/Clinical Information and Learning Management, EMD Serono
This session will provide an overview of the overall (blended) training concept for ICH GCP training at EMD Serono, as well as strategies for a creative training design that is tailored to the training needs of various groups within Clinical Research. The audience will learn how to integrate the “fun” factor to a topic normally considered to be very theoretical and “dry.” Examples of activities and exercises used in compliance training with high impact interaction for guaranteed learning transfer. Presenters will introduce a state-of-the-art activating learning approach to ICH GCP training that has been very successful in the past two years at EMD Serono.
2:15 Learning Styles and Learner Adaptability: Impact on Clinical Training Design
Gregg Van Citters,Ph.D., Sr. Clinical Research Training Specialist, Medtronic Diabetes, Inc.
Clinical research operations require a detail orientation for successful compliance. Paradoxically, clinical research by nature requires diametrically opposed skills to cope with the constantly changing clinical, regulatory, and business environment. Effective training across the spectrum requires adaptability on the part of the trainer and the learners to ensure transfer of knowledge, skills, and influencing attitudes. We will explore training and learning styles and the adaptability of each in a clinical human performance environment. The desired outcome of any training in the clinical research environment is to effectively influence human performance. Trainers may not be aware of their own training styles or the need to adapt to the situation and the learner. Simple tools and awareness of the issues surrounding training and learning styles can make learning more effective to achieve sustained performance. Attendees will walk away with an appreciation of dominant training and learning styles, and how to adapt them to any training/learning situation.
3:00 Refreshment Break and Exhibit Viewing
3:15 Roundtable Session #3:
Training Techniques Toolbox: Best Practices from “Expert” Trainers
In this interactive session, attendees will break into roundtable sessions facilitated by seasoned trainers to share techniques, best practices, and pitfalls to avoid around the following issues:
INVESTIGATOR MEETING TRAINING INITIATIVES
Results of each roundtable will be compiled and shared with all groups at the end of the session.
4:00 Investigator Training: Making the Investigator Meeting Work for You
Maria C. Mancini, MHP, RAC, Principal Associate, Cardiovascular Clinical Research, Genzyme
Nowadays, conducting a clinical study is more complicated than ever. Increasingly complex protocols, new technologies, and increased regulatory scrutiny have all made study implementation more challenging. Considering that sites may be participating in several studies at any given time, often with different sponsors, it becomes apparent that there is a lot of room for error on the site’s part. How should a Sponsor support their sites for this large undertaking? Traditionally, the Sponsor will hold an investigator meeting where several hundred doctors and study coordinators assemble in a central location in order to soak up the protocol details, ask questions, and otherwise prepare themselves for participating in the upcoming study. This is an age-old practice, but is it still viable? Are the doctors and study coordinators taking information away from the meeting? Do steps need to be taken to provide training that is not only more effective but delivered in a more efficient manner as well? This session will review the typical characteristics identified at an investigator meeting, evaluate what aspects are capable of being changed or updated to reflect current thinking and technology, and come up with a model for the next generation investigator meeting.
4:45 Industry Standardization of GCP Investigator Training
Rhea Bagnell, Manager, Operational Performance Strategies, Pfizer Global Research and Development Manager
Before being considered competent to manage a clinical trial, Investigator GCP training is a basic requirement, therefore all pharmaceutical companies have similar needs for GCP training. This presentation will focus on why it makes sense for companies managing clinical trials to leverage collaboration regarding GCP training and create a standard, benchmarked curriculum. The benefits to industry would be to (1) standardize GCP knowledge, (2) reduce training costs, and (3) increase study quality. Additionally, by standardizing how clinical trial investigators are educated, trained, and evaluated against the regulations and standards, regulatory compliance becomes more transparent.
5:30 Chairperson’s Closing Remarks
5:45 Close of Conference
For more information, please contact:
Barnett Internationala division of Cambridge Healthtech InstituteEmail: firstname.lastname@example.org
Phone: (413) 527-3056
For exhibit and sponsorship information, please contact:Arnie Wolfson
Manager, Business Development
a division of Cambridge Healthtech Institute
250 First Avenue Suite 300Needham, MA 02494P: 781.972.5400F: 781.972.5425E: email@example.com
biological therapeutic productsbiomarkers & diagnosticsbiopharma strategybioprocess & manufacturingchemistryclinical trials & translational medicinedrug & device safety
drug discovery & developmentdrug targetsgenomicshealthcareit & informaticstechnology & tools for life sciencetherapeutic indications
conferencesreportsbarnett educational servicesconsultingpublications & eNewslettersprofessional services
executive teamtestimonialschi timelinemailing listcareers